Instrument access device

ABSTRACT

An instrument access device ( 500 ) comprises a distal O-ring ( 11 ) for insertion into a wound interior, a proximal member for location externally of a wound opening and a sleeve ( 12 ) extending in two layers between the distal O-ring ( 11 ) and the proximal member. The proximal member comprises an inner proximal ring member ( 25 ) and an outer proximal ring member ( 24 ) between which the sleeve ( 12 ) is led. A seal housing ( 300 ) is mounted to the inner proximal ring member ( 25 ). A gelatinous elastomeric seal ( 302 ) with a pinhole opening ( 303 ) therethrough is received in the housing ( 300 ). An instrument may be extended through the seal ( 302 ) to access the wound interior through the retracted wound opening in a sealed manner.

This application is a Continuation of application Ser. No. 13/175,822,filed on Jul. 1, 2011, now U.S. Pat. No. 8,888,693, which is aContinuation of application Ser. No. 11/246,909, filed on Oct. 11, 2005,now U.S. Pat. No. 7,998,068.

Application Ser. No. 11/246,909, filed on Oct. 11, 2005, is aContinuation-In-Part of U.S. application Ser. No. 10/736,234, filed onDec. 16, 2003, which claims the benefit of U.S. Provisional ApplicationNo. 60/433,603, filed on Dec. 16, 2002, and 60/453,200, filed on Mar.11, 2003.

Application Ser. No. 11/246,909, filed on Oct. 11, 2005, is also aContinuation-In-Part of U.S. application Ser. No. 10/678,653, filed onOct. 6, 2003, now U.S. Pat. No. 7,559,893, which is aContinuation-In-Part of Ser. No. 10/133,979, filed on Apr. 29, 2002, nowU.S. Pat. No. 6,846,287, which is a Continuation of U.S. applicationSer. No. 09/801,826, filed on Mar. 9, 2001, which is a Continuation ofPCT/IE99/00122, filed on Dec. 1, 1999. Application Ser. No. 10/678,653,filed on Oct. 6, 2003, is also a Continuation-In-Part of U.S.application Ser. No. 10/374,523, filed on Feb. 27, 2003, now U.S. Pat.No. 7,445,597, which is a Continuation of U.S. application Ser. No.09/849,341, filed on May 7, 2001, now U.S. Pat. No. 6,582,364, which isa Continuation of U.S. application Ser. No. 09/688,138, filed on Oct.16, 2000, now U.S. Pat. No. 6,254,534. Application Ser. No. 10/678,653,filed on Oct. 6, 2003, claims the benefit of U.S. ProvisionalApplication No. 60/415,780, filed on Oct. 4, 2002, U.S. ProvisionalApplication No. 60/428,215, filed on Nov. 22, 2002, and U.S. ProvisionalApplication No. 60/490,909, filed on Jul. 30, 2003.

Application Ser. No. 11/246,909, filed on Oct. 11, 2005, is also aContinuation-In-Part of U.S. application Ser. No. 10/665,395, filed onSep. 22, 2003, now U.S. Pat. No. 7,867,164, which is aContinuation-In-Part of U.S. application Ser. No. 10/374,523, filed onFeb. 27, 2003, now U.S. Pat. No. 7,445,597, which is a Continuation ofU.S. application Ser. No. 09/849,341, filed on May 7, 2001, now U.S.Pat. No. 6,582,364, which is a Continuation of U.S. application Ser. No.09/688,138, filed on Oct. 16, 2000, now U.S. Pat. No. 6,254,534, andclaims the benefit of U.S. Provisional Application No. 60/490,909, filedon Jul. 30, 2003.

Application Ser. No. 11/246,909, filed on Oct. 11, 2005, is also aContinuation-In-Part of U.S. application Ser. No. 10/374,523, filed onFeb. 27, 2003, now U.S. Pat. No. 7,445,597, which is a Continuation ofU.S. application Ser. No. 09/849,341, filed on May 7, 2001, now U.S.Pat. No. 6,582,364, which is a Continuation of U.S. application Ser. No.09/688,138, filed on Oct. 16, 2000, now U.S. Pat. No. 6,254,534.

Application Ser. No. 11/246,909, filed on Oct. 11, 2005, is also aContinuation-In-Part of U.S. application Ser. No. 10/133,979, filed onApr. 29, 2002, now U.S. Pat. No. 6,846,287, which is a Continuation ofU.S. application Ser. No. 09/801,826, filed on Mar. 9, 2001, which is aContinuation of PCT/IE99/00122, filed on Dec. 1, 1999.

Application Ser. No. 11/246,909, filed on Oct. 11, 2005, now U.S. Pat.No. 7,998,068, is also a Continuation-In-Part of U.S. application Ser.No. 10/902,440, filed on Jul. 30, 2004, which is a Continuation-In-Partof U.S. application Ser. No. 10/736,234, filed on Dec. 16, 2003, whichclaims the benefit of U.S. Provisional Application Nos. 60/433,603,filed on Dec. 16, 2002, and 60/453,200, filed on Mar. 11, 2003.Application Ser. No. 10/902,440, filed on Jul. 30, 2004 is also aContinuation-In-Part of U.S. application Ser. No. 10/678,653, filed onOct. 6, 2003, now U.S. Pat. No. 7,559,893, which is aContinuation-In-Part of Ser. No. 10/133,979, filed on Apr. 29, 2002, nowU.S. Pat. No. 6,846,287, which is a Continuation of U.S. applicationSer. No. 09/801,826, filed on Mar. 9, 2001, which is a Continuation ofPCT/IE99/00122, filed on Dec. 1, 1999. Application Ser. No. 10/678,653,filed on Oct. 6, 2003, also is a Continuation-In-Part of U.S.application Ser. No. 10/374,523, filed on Feb. 27, 2003, now U.S. Pat.No. 7,445,597, which is a Continuation of U.S. application Ser. No.09/849,341, filed on May 7, 2001, now U.S. Pat. No. 6,582,364, which isa Continuation of U.S. application Ser. No. 09/688,138, filed on Oct.16, 2000, now U.S. Pat. No. 6,254,534. Application Ser. No. 10/678,653,filed on Oct. 6, 2003 claims the benefit of U.S. Provisional ApplicationNo. 60/415,780, filed on Oct. 4, 2002, U.S. Provisional Application No.60/428,215, filed on Nov. 22, 2002, and U.S. Provisional Application No.60/490,909, filed on Jul. 30, 2003. Application Ser. No. 10/902,440,filed on Jul. 30, 2004, is also a Continuation-In-Part of U.S.application Ser. No. 10/665,395, filed on Sep. 22, 2003, now U.S. Pat.No. 7,867,164, which is a Continuation-In-Part of U.S. application Ser.No. 10/374,523, filed on Feb. 27, 2003, now U.S. Pat. No. 7,445,597,which is a Continuation of U.S. application Ser. No. 09/849,341, filedon May 7, 2001, now U.S. Pat. No. 6,582,364, which is a Continuation ofU.S. application Ser. No. 09/688,138, filed on Oct. 16, 2000, now U.S.Pat. No. 6,254,534, and claims the benefit of U.S. ProvisionalApplication No. 60/490,909, filed on Jul. 30, 2003. Application Ser. No.10/902,440, filed on Jul. 30, 2004 is also a Continuation-In-Part ofU.S. application Ser. No. 10/374,523, filed on Feb. 27, 2003, now U.S.Pat. No. 7,445,597, which is a Continuation of U.S. application Ser. No.09/849,341, filed on May 7, 2001, now U.S. Pat. No. 6,582,364, which isa Continuation of U.S. application Ser. No. 09/688,138, filed on Oct.16, 2000, now U.S. Pat. No. 6,254,534. Application Ser. No. 10/902,440,filed on Jul. 30, 2004 is also a Continuation-In-Part of U.S.application Ser. No. 10/315,233, filed on Dec. 10, 2002, which is aContinuation of U.S. application Ser. No. 09/804,552, filed on Mar. 13,2001, now U.S. Pat. No. 6,578,577, which is a Continuation ofPCT/IE99/00123, filed on Dec. 1, 1999. Application Ser. No. 10/902,440,filed on Jul. 30, 2004 is also a Continuation-In-Part of U.S.application Ser. No. 10/133,979, filed on Apr. 29, 2002, now U.S. Pat.No. 6,846,287, which is a Continuation of U.S. application Ser. No.09/801,826, filed on Mar. 9, 2001, which is a Continuation ofPCT/IE99/00122, filed on Dec. 1, 1999. Application Ser. No. 10/902,440,filed on Jul. 30, 2004 also claims the benefit of U.S. ProvisionalApplication No. 60/490,909, filed on Jul. 30, 2003.

Application Ser. No. 11/246,909, filed on Oct. 11, 2005, now U.S. Pat.No. 7,998,068, also claims the benefit of U.S. Provisional ApplicationNo. 60/617,094, filed on Oct. 12, 2004, and U.S. Provisional ApplicationNo. 60/699,370 filed on Jul. 15, 2005.

Application Ser. No. 11/246,909, filed on Oct. 11, 2005, now U.S. Pat.No. 7,998,068, also claims the benefit of Ireland Application Nos.990107, 990108, 990109, 990110, 990111, and 990112, filed on Feb. 15,1999; Ireland Application No. 990416, filed on May 24, 1999; IrelandApplication Nos. 980997 and 980999, filed on Dec. 1, 1998; IrelandApplication No. 991053, filed on Dec. 16, 1999; Ireland Application No.990861, filed on Oct. 14, 1999; Ireland Application No. 2002/0754, filedon Sep. 19, 2002; Ireland Application No. 2004/0686, filed on Oct. 11,2004; International Application Nos. PCT/IE/99/00122 andPCT/IE/99/00123, filed on Dec. 1, 1999; and European Application No.00650010, filed on Feb. 18, 2000.

The contents of all of these applications and patents are hereinincorporated by reference in their entirety.

INTRODUCTION

Accessing the abdominal cavity while preserving the abdominal wall asmuch as possible is the aim of any surgical or exploratory procedure.Retraction devices have been used to this end. A retractor can help toexpose an operative site and minimise the incision required to carry outthe operation.

Minimally invasive surgery is an evolving surgical method that similarlyattempts to reduce the size of incisions required, in many casesdramatically. By using a so-called “keyhole” or cannula, the surgeon cangain access with instruments into the abdominal cavity to carry out anoperation through a very small series of holes in the abdominal wall.Unlike in the case of “open surgery”, primary retraction then must beaccomplished by lifting the abdominal wall away from the abdominalviscera. This is most often accomplished with the use of gas in atechnique known as insufflation.

The use of a cannula to gain access as a means to see inside the abdomenor introduce surgical instruments has existed since the late 19^(th)century. A cannula comprises a rigid tube, which is inserted through theabdominal wall and is held in place by the tension of the abdominal wallitself around the inserted cannula. The tube must accommodate variousthicknesses of abdominal wall and extend significantly both inside andoutside the abdomen to avoid slipping out of the incision, and therebycausing gas pressure to escape.

The basic construction of a cannula, however, presents significantlimitations in carrying out a surgical procedure. Some of theselimitations are as follows.

-   1. A cannula is held in place, and thus prevents the escape of gas,    by tissue tension. This tension can vary depending on the way the    cannula is introduced or weaken during the operation under normal    surgical manipulation.-   2. A cannula extends significantly into the abdominal cavity taking    up precious space and interfering with other instruments.-   3. A cannula restricts the movement of instruments as they are rigid    structures.-   4. A rigid cannula presents significant limitations on the design of    the instrument which must be passed through the cannula.-   5. A cannula takes up a significant space outside of the abdomen,    shortening the effective length, and therefore reach, of the    surgical instrument.

This invention is directed towards providing an instrument access devicewhich will address at least some of these problems.

STATEMENTS OF INVENTION

According to the invention there is provided an instrument access devicecomprising:—

-   -   a distal anchoring member for insertion into a wound interior;    -   an elongate member extending proximally from the distal        anchoring member to retract laterally the sides of a wound        opening; and    -   an instrument working channel through which an instrument may        extend to access the wound interior.

In one embodiment of the invention the device comprises a proximalmember for location externally of a wound opening. The proximal membermay comprise a ring member. The proximal member may comprise a proximalinner element and a proximal outer element. The elongate member may beled between the proximal inner element and the proximal outer element.The proximal inner element and/or the proximal outer element maycomprise a ring element. The proximal outer element may be mounted tothe proximal inner element. The proximal outer element may bedemountable from the proximal inner element.

In one case the proximal outer element comprises an engagement surfacefor resting upon the proximal inner element to mount the proximal outerelement to the proximal inner element. The engagement surface maycomprise a curved surface. The engagement surface may extend incross-section for substantially a quarter-revolution. The engagementsurface may be configured to engage a proximal side of the proximalinner element.

In another case the device comprises a clamp for clamping the instrumentworking channel in position. The clamp may be configured to clamp theelongate member to the instrument working channel. The clamp maycomprise a proximal clamp. The clamp may be defined by the proximalouter element and the proximal inner element. The proximal outer elementmay comprise a proximal outer ring. The proximal inner element maycomprise a proximal inner ring. The proximal inner element may bedefined by a portion of the instrument working channel.

In another embodiment the device comprises at least one instrument sealor valve. The seal or valve may comprise a gelatinous elastomericmaterial. The seal or valve may comprise at least one opening extendingtherethrough through which an instrument may be extended. The openingmay be biased towards a closed configuration. The opening may comprise apinhole opening.

In one case the seal or valve is piercable to create at least oneopening extending therethrough through which an instrument may beextended. The seal or valve may be piercable by an instrument to createan opening extending therethrough.

In another case the seal or valve comprises an insufflation lumenextending therethrough. The longitudinal axis of the insufflation lumenmay be substantially parallel to the longitudinal axis of the device.

In another embodiment the device comprises a housing for an instrumentseal or valve. The housing may comprise a reception space for receivingan instrument seal or valve. The reception space may have an inletthrough which an instrument seal or valve may be located in thereception space. The inlet may face proximally.

In one case the housing comprises a retainer to retain an instrumentseal or valve in the reception space. The retainer may comprise a capfor at least partially closing the inlet. The retainer may comprise anopening to facilitate access to an instrument seal or valve in thereception space. The retainer may be substantially annular in shape.

In another case the housing comprises a locator to assist in locating aseal or valve in the reception space. The locator may comprise at leastone male member for co-operative association with at least onecorresponding female member.

In one embodiment the housing comprises an insufflation lumen extendingtherethrough. The longitudinal axis of the insufflation lumen may besubstantially parallel to the longitudinal axis of the device. Thehousing insufflation lumen may be aligned with an insufflation lumen ofan instrument seal or valve. The device may comprise an insufflationseal or valve for the insufflation lumen. The insufflation seal or valvemay be provided at a proximal end of the insufflation lumen. Theinsufflation seal or valve may be pierceable by an insufflation tube.

In one case the access device comprises an intermediate connector toconnect the insufflation lumen in communication with an insufflationtube. The intermediate connector may be configured to connect aninsufflation tube in communication with the insufflation lumen with thelongitudinal axis of the insufflation tube at a distal end of theinsufflation tube inclined relative to the longitudinal axis of theinsufflation lumen. The intermediate connector may be configured toconnect an insufflation tube in communication with the insufflationlumen with the longitudinal axis of the insufflation tube at a distalend of the insufflation tube substantially perpendicular to thelongitudinal axis of the insufflation lumen.

In a further case the housing is mounted to the proximal member. Thehousing may be mounted to the proximal inner element. The housing mayextend distally of the proximal inner element. The housing may belocated radially inwardly of the proximal inner element. The housing maybe demountable from the proximal inner element.

In one case the device comprises a seal across the proximal innerelement. The seal may be piercable by the housing and/or by theinstrument working channel upon mounting of the housing to the proximalinner element.

In a further embodiment the housing is formed integrally with theproximal inner element.

The housing may define the proximal inner element.

In one case the device comprises a sleeve extending from the proximalinner element to the housing. The sleeve may be formed integrally withthe elongate member.

In one embodiment the housing at least in part defines the instrumentworking channel. The instrument working channel may be mounted to thehousing. The instrument working channel may be demountable from thehousing. In one case the instrument working channel is formed integrallywith the housing.

In one embodiment the instrument working channel is defined by a tubularmember. The tubular member may be substantially rigid over at least partof its length. The tubular member may define a lumen extendingtherethrough through which an instrument may be extended. The tubularmember may have a distal opening at a distal end of the tubular member.The distal opening may be inclined relative to the longitudinal axis ofthe tubular member. The plane of the distal opening may be inclinedrelative to the longitudinal axis of the tubular member. The tubularmember may have a low-profile leading end. The leading end may betapered. The leading end may be tapered to a point. The distal end ofthe tubular member may be skived.

In another embodiment the instrument working channel is mounted to theproximal member. The instrument working channel may be mounted forcontrolled movement relative to the proximal member. The device maycomprise a sleeve extending between the instrument working channel andthe proximal member to mount the instrument working channel to theproximal member.

In one case the elongate member comprises a sleeve. At least a portionof the sleeve may comprise two material layers. The sleeve may bewrapped around the distal anchoring member. The sleeve may be slidablymovable relative to the distal anchoring member. The sleeve may comprisea single material layer. An end of the sleeve may be fixed to the distalanchoring member.

In a further case the elongate member extends from the distal anchoringmember to at least the proximal member. The elongate member may beslidably movable over at least a portion of the proximal member. Theelongate member may be slidably movable over the proximal inner element.An end of the elongate member may be fixed to the proximal member. Anend of the elongate member may be fixed to the housing. The elongatemember may be fixed to the proximal member at one end, the elongatemember may extend from the proximal member to the distal anchoringmember to define an inner material layer, and the elongate member mayextend from the distal ring anchoring member to the proximal member todefine an outer material layer.

In one case the distal anchoring member comprises a distal ring. Thedistal ring may be formed from an elastomeric material.

The device may comprise at least one proximal handle for manipulatingthe device, in situ.

In another aspect of the invention there is provided an instrumentaccess device comprising: —

-   -   a distal ring;    -   a proximal ring;    -   a sleeve having a portion between the distal ring and the        proximal ring that includes two material layers; and    -   an instrument seal or valve mounted to the proximal ring.

In one embodiment the sleeve is fixed to the proximal ring at one end,the sleeve extends from the proximal ring to the distal ring to definean inner material layer, and the sleeve extends from the distal ring tothe proximal ring to define an outer material layer. The sleeve may beslidingly received over a portion of the proximal ring.

In one case the proximal ring comprises an inner proximal ring memberand an outer proximal ring member between which the sleeve is led.

The instrument also provides in another aspect an instrument accessdevice comprising: —

-   -   a distal ring;    -   a proximal ring;    -   a sleeve having a portion between the distal ring and the        proximal ring; and    -   an instrument seal or valve comprising a gelatinous elastomeric        material for receiving an instrument.

The gelatinous elastomeric material may have a pinhole to receive aninstrument.

In a further aspect, the invention provides an instrument access devicecomprising:—

-   -   a distal anchoring member for insertion into a wound interior;    -   a proximal member for location externally of a wound opening;    -   a sleeve extending in two layers at least between the distal        anchoring member and the proximal member; and    -   an instrument seal or valve comprising a gelatinous elastomeric        material for receiving an instrument.

The invention also provides in another aspect an instrument accessdevice comprising:—

-   -   a distal anchoring member for insertion into a wound interior;    -   a proximal member for location externally of a wound opening;    -   an elongate member extending at least between the distal        anchoring member and the proximal member;    -   the proximal member comprising a proximal inner element and a        proximal outer element between which the elongate member is led;        and    -   an instrument seal or valve mounted to the proximal inner        element.

According to another aspect of the invention there is provided a methodof accessing a wound interior with an instrument, the method comprisingthe steps of: —

-   -   inserting a distal anchoring member through an incision, the        distal anchoring member having an elongate member attached        thereto;    -   presenting an instrument working channel member to the incision;    -   pulling the elongate member upwardly relative to the instrument        working channel member to at least partially insert the        instrument working channel member into the incision; and    -   inserting an instrument through the incision.

In one embodiment the elongate member lies at least in part between theinstrument working channel member and the walls of the incision.

In one case the incision is a laparoscopic incision. The sides of theincision may be retracted to a diameter of less than 40 mm. The sides ofthe incision may be retracted to a diameter of between 3 mm and 35 mm.The sides of the incision may be retracted to a diameter of between 5 mmand 12 mm.

In another case the sides of the incision are retracted to a diametersubstantially equal to a diameter of the instrument working channelmember.

The sides of the incision may be at least partially retracted byinsertion of the instrument working channel member into the incision.The sides of the incision may be at least partially retracted by pullingof the elongate member upwardly relative to the instrument workingchannel member.

In one case the instrument is a laparoscopic instrument. The instrumentmay have a diameter of less than 40 mm. The instrument may have adiameter of between 3 mm and 35 mm. The instrument may have a diameterof between 5 mm and 12 mm.

In one case after insertion of the instrument working channel memberinto the incision, the distal end of the instrument working channelmember is located within the wound interior distally of the incision. Inanother case after insertion of the instrument working channel memberinto the incision, the distal end of the instrument working channelmember is located within the incision proximally of the wound interior.

In one embodiment the leading end of the instrument working channelmember is guided into the incision. The instrument working channelmember may be configured to automatically guide the leading end into theincision.

The method may comprise the step of sealing the incision. The method maycomprise the steps of insufflating the wound interior. The woundinterior may be insufflated after insertion of the instrument workingchannel member into the incision.

In another aspect the invention provides a method of retracting a woundopening, the method comprising the steps of: —

-   -   inserting a distal anchoring member through a wound opening into        a wound interior;    -   locating a proximal member externally of the wound opening with        an elongate member extending at least between the distal        anchoring member and the proximal member;    -   locating a guide member externally of the wound opening;    -   moving the guide member and the proximal member relative to the        elongate member to retract laterally the sides of the wound        opening; and    -   removing the guide member while the distal anchoring member, the        proximal member and the elongate member remain in position        retracting the wound opening.

In one case the elongate member is led between the proximal member andthe guide member.

The elongate member may extend in two layers between the proximal memberand the distal anchoring member.

In another case the proximal member is moved by pushing the guide memberwhich engages the proximal member.

The invention also provides in a further aspect a method of retracting awound opening, the method comprising the steps of: —

-   -   inserting a distal anchoring member through a wound opening into        a wound interior;    -   locating a proximal member externally of the wound opening with        an elongate member extending at least between the distal        anchoring member and the proximal member;    -   moving the proximal member relative to the elongate member to        retract laterally the sides of the wound opening; and    -   mounting a first seal or valve to the proximal member.

In one embodiment the first seal or valve is mounted to the proximalmember after retraction of the wound opening. The first seal or valvemay be mounted to the proximal member before retraction of the woundopening.

In one case the method comprises the step of piercing a second seal. Thesecond seal may be pierced upon mounting of the first seal or valve tothe proximal member.

In a further aspect of the invention there is provided a method ofretracting a wound opening, the method comprising the steps of:—

-   -   inserting a distal anchoring member through a wound opening into        a wound interior;    -   locating a proximal member externally of the wound opening with        an elongate member extending at least between the distal        anchoring member and the proximal member; and    -   by means of a single actuation step, moving the proximal member        relative to the elongate member to retract laterally the sides        of the wound opening.

In one embodiment the entire circumference of the proximal member ismoved together relative to the entire circumference of the elongatemember.

The proximal member may be pushed distally relative to the elongatemember. The elongate member may be pulled proximally relative to theproximal member. The proximal member may be moved relative to theelongate member in a single direction. The proximal member may be movedrelative to the elongate member in a direction substantially parallel tothe longitudinal axis of the wound opening.

In one case the method comprises the step of gripping the proximalmember. The proximal member may be gripped by a single hand of a user.Opposite sides of the proximal member may be gripped by a single hand ofa user. The method may comprise the step of gripping the elongatemember. The elongate member may be gripped by a single hand of a user.The entire circumference of the elongate member may be gripped by asingle hand of a user.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the followingdescription of some embodiments thereof, given by way of example only,with reference to the accompanying drawings, in which:—

FIG. 1 is a perspective view of a liner part of an instrument accessdevice of the invention;

FIG. 2 is a cross sectional, side view of the liner part of FIG. 1inserted in an incision;

FIG. 3 is a perspective view of a tubular member defining an instrumentworking channel of the access device;

FIG. 4 is a cross sectional, side view of the access device in place inan incision;

FIG. 5 is a cross-sectional, side view similar to FIG. 4 illustratingclamping or anchoring of the tubular member;

FIGS. 6 and 7 are views similar to FIGS. 1 and 2 of an alternative linerpart with a proximal valve or seal;

FIGS. 8 and 9 are views similar to FIGS. 4 and 5 with the liner part ofFIGS. 6 and 7, in use;

FIGS. 10 and 11 are views similar to FIGS. 4 and 5 of an alternativetubular member with a proximal valve or seal, in use;

FIG. 12 is a cross sectional, side view of an instrument access deviceof the invention; in use;

FIG. 13 is a cross sectional, side view of another instrument accessdevice of the invention, in use;

FIGS. 14 to 16 are cross sectional, side views of a further instrumentaccess device of the invention, in use;

FIGS. 17 to 19 are cross sectional, side views of alternative instrumentaccess devices of the invention, with different tubular members;

FIG. 20 is a perspective view of one of the tubular members of FIGS. 17to 19;

FIG. 21 is a cross sectional, perspective view of the tubular member ofFIG. 20;

FIG. 22 is a perspective view of a housing part of the access device ofthe invention;

FIG. 23 is a cross sectional, perspective view of the housing part ofFIG. 22;

FIGS. 24 and 25 are exploded, perspective views of an outer proximalring and housing part assembly of the access device of the invention;

FIGS. 26 to 28 are cross sectional, side views of another instrumentaccess device of the invention, in use;

FIGS. 29 and 30 are cross sectional, side views of a further instrumentaccess device of the invention, in use;

FIGS. 31 and 32 are cross sectional, side views of another instrumentaccess device of the invention;

FIGS. 33 to 37 are cross-sectional, side views of a further instrumentaccess device of the invention;

FIGS. 38 and 39 are cross sectional, side views of a still furtherinstrument access device of the invention;

FIGS. 40 to 42 are cross sectional, side views of another instrumentaccess device of the invention;

FIG. 43 is a cross sectional, side view of a further instrument accessdevice of the invention;

FIGS. 44 to 46 are cross sectional, side views of another instrumentaccess device of the invention;

FIGS. 47 to 49 are cross sectional, side views of a further instrumentaccess device of the invention;

FIGS. 50 to 55 are views of another instrument access device of theinvention;

FIGS. 56 to 58 are cross sectional, side views of a further instrumentaccess device of the invention;

FIG. 58(a)(i) is a cut-away, perspective view of another instrumentaccess device according to the invention;

FIG. 58(a)(ii) is an exploded, perspective view of a part of the deviceof FIG. 58(a)(i);

FIG. 58(b) is an assembled, perspective view of the part of theinstrument access device of FIG. 58(a)(ii);

FIG. 58(c)(i) is a cut-away, perspective view of the part of theinstrument access device of FIG. 58 (a)(ii);

FIGS. 58(c)(ii) and 58(c)(iii) are cross-sectional, side views of thedevice of FIG. 58(a)(i), in use;

FIGS. 58(d) and 58(e) are views similar to FIGS. 58(a)(ii) and 58(c)(i)of part of another instrument access device according to the invention;

FIGS. 58(f) and 58(g) are partially cross-sectional, side views ofanother instrument access device according to the invention, in use;

FIGS. 58(h) and 58(i) are partially cross-sectional, side views of afurther instrument access device according to the invention, in use;

FIGS. 59 to 61 are cross sectional, side views of another instrumentaccess device of the invention;

FIGS. 62 to 64 are cross sectional, side views of a further instrumentaccess device of the invention;

FIG. 65 is a cross sectional, side view of another instrument accessdevice according to the invention;

FIG. 66 is a cut-away, perspective view of a part of the device of FIG.65;

FIG. 67 is an end view of the part of FIG. 66;

FIGS. 68 to 70 are cross-sectional, side views of the device of FIG. 65,in use;

FIGS. 70(a) to 70(f) are cross-sectional, side views of anotherinstrument access device according to the invention, in use;

FIGS. 70(g) to 70(i) are cross-sectional, side views of anotherinstrument access device according to the invention, in use; and

FIGS. 71 to 73 are cross-sectional, side views of a further instrumentaccess device according to the invention, in use.

DETAILED DESCRIPTION

Referring to the drawings there are illustrated various instrumentaccess devices of the invention for an incision 1, for example in anabdominal wall 2. The construction of the various components and theirattributes will be explained in detail below. In some cases, theinstrument access device is used as a substitute for a conventionalrigid tubular cannula. The instrument access devices of the inventionmay be used to provide access to the abdominal cavity by an instrument3, which in this case has an operating element 4, such as a surgicalstapler, mounted at the distal end of a flexible shaft 5.

It will be noted that the devices have a very low profile, especiallywith respect to the inside of the incision 1. The devices are positivelyretained in the incision 1 against pull-out forces. Because of the lowprofile the shaft 5 of the instrument 3 can begin bending immediatelyafter entering the abdominal cavity. The amount of free space requiredto manipulate the instrument 3 is minimised. This is in contrast to aconventional cannula, in which the rigid tube of the cannula must beextended significantly into the abdomen to ensure that it remainsanchored in the abdomen, otherwise gas pressure may cause it to becomedislodged. In conventional systems, because of the cannula lengthextending into the abdomen, the shaft 5 of the instrument 3 cannot besteered until the steerable section has exited the cannula. Thus, thereare severe limitations on the use of such instruments using aconventional cannula. These problems are overcome at least in part usingthe instrument access devices of the invention.

Referring initially to FIGS. 1 and 2 there is illustrated a liner part10 of the access device. The liner part 10 comprises a distal anchoringmember 11 and an elongate member 12 extending proximally of the distalanchoring member 11.

In this case, the elongate member is provided in the form of a sleeve 12of flexible, polymeric film material which lines the sides of the woundopening 13, in use. The distal anchoring member 11 in this casecomprises a resilient O-ring.

An instrument working channel is in this case defined by a tubularmember 15 which may be substantially rigid along at least portion of thelength thereof.

In use, a relatively small incision 1 is made in an abdominal wall 2 toform the wound opening 13. A typical length for the incision 1 is in therange of from 12 mm to 30 mm. The resilient distal O-ring 11 is thenmanipulated into an elongate, oblong shape by squeezing the distalO-ring 11 to facilitate insertion of the distal O-ring 11 through thewound opening 13, until the distal O-ring 11 is fully located within theabdominal cavity and the sleeve 12 lines the wound opening 13. Thetubular member 15 is then presented to the wound opening 13 inside thesleeve 12. The sleeve 12 is then pulled upwardly relative to the tubularmember 15 to cause the tubular member 15 to enter the wound opening 13and to cause the distal O-ring 11 to engage with the internal surface ofthe abdominal wall.

The tubular member 15 is clamped or anchored to the sleeve 12 by asuitable clamp such as a proximal clamp 17.

The use of the tubular member 15 provides an enhanced instrument workingchannel through the wound opening 13. It assists in preventing collapseof the sides of the wound opening 13. There is less friction as theinstrument 3 is inserted and manipulated. Importantly, the tubularmember 15 assists in providing a device that has a very low profile withthe consequent advantages of maximising the surgeon's freedom ofmovement.

Any suitable valve or seal or combinations of valves and/or seals may beprovided for an instrument. Such valve or valves are genericallyindicated by an X and by the reference numeral 20 in the drawings. Inone arrangement (FIGS. 6 to 9) a valve 20 is provided at a proximal endof the sleeve 12. In another arrangement a valve 20 is provided at aproximal end of the tubular member 15 (FIGS. 10 and 11). Indeed valves20 may be provided both on the sleeve 2 and on the tubular member 15.

The sleeve 12 may be a single layer sleeve or may have two layers atleast in the section which lines the wound opening 13. One sucharrangement is illustrated in FIG. 12 in which the sleeve 12 is wrappedaround the distal ring 11 and has an outer layer 22 which lines thewound opening 13 and an inner layer 23. A clamp is in this case aproximal clamp comprising an outer proximal ring member 24 and an innerproximal ring member 25 between which the sleeve 12 extends. In thiscase the inner proximal clamp is mounted to or provided by part of ahousing 27 for a valve 20. The sleeve 12 is mounted at one end to thering member 25 or housing 27 and extends to form the inner layer 23, iswrapped around the distal ring 11 and extends to form the outer layer22. The sleeve 12 is slidable on at least portion of the inner proximalclamp ring 25 and the sleeve 12 is slidable relative to the distal ring11. On pulling of the sleeve 12 upwardly the wound opening 13 isretracted. Because of the sleeve pathway a free end of the sleeve 12 isexternal of the valve 20 and can be readily removed, if desired. In thiscase the proximal ring member 25 is formed integrally with the housing27.

Referring now to FIGS. 13 to 16 there is illustrated an instrumentaccess device having a valve housing 27 and an instrument workingchannel defined by a tubular member or stub 40 which extends into thewound opening 13 from the valve housing 27. The tubular member 40 neednot necessarily extend fully into the wound opening. In the arrangementof FIG. 13 it is shown extending only partially through the woundopening whilst in FIGS. 14 to 16 the tubular member 40 extends fully thethickness of the abdomen. The valve housing 27 in this case also has aninsufflation port 42. In this case the tubular member 40 is formedintegrally with the housing 27.

The tubular member 40 may be detachably mounted to the valve housing 27as illustrated particularly in FIGS. 17 to 25. In this way the accessdevice may be adapted for different situations such as different sizedabdomens or depending on the degree of access required by the surgeon.The tubular members 40 may be of varying lengths, as illustrated. Anysuitable mounting may be provided between the tubular member 40 and thevalve housing 27 such as adhesive, an interference fit, a spigot andsocket, screw threaded, or bayonet type fitting.

Referring to FIGS. 24 and 25 the outer proximal clamp ring member may besplit into sections 24 a, 24 b for ease of assembly, disassembly. Thering sections 24 a, 24 b can be assembled and fixed using any suitablemeans such as adhesive or the like.

Referring to FIGS. 26 to 28 there is illustrated a further instrumentaccess device according to the invention. In this case a seal in theform of a sheet 50 of film material is extended across the innerproximal ring 25 to maintain pneumoperitoneum. The tubular member 40 hasa tapered distal end 55 for ease of breaking through the film 50 asillustrated in FIG. 27. The valve housing 27 in this case is configuredat 56 to snap fit over an outer proximal ring 24 for assembly of thevalve housing 27 to the retractor base. The access device is illustratedin use in FIG. 28.

Referring to FIGS. 29 and 30 the access device in this case has agripper or handle provided by an anchor eye 57 and a lifting wire 58. Onpulling of the lifting wire 58 upwardly as indicated by the arrow inFIG. 30 the device can be easily tilted providing easier access to moreareas of the abdomen. The force on the lifting wire 58 can be varied toincrease or decrease the angle alpha to provide further desired access.

Referring to FIGS. 31 and 32 there is illustrated another instrumentaccess device which is similar to those described above and like partsare assigned the same reference numerals. In this case the tubularmember 40 is detachable and a suitable tubular member 40 is attached tothe valve housing 27 prior to deployment in a patient.

Referring to FIGS. 33 to 37 there is illustrated the method of using adevice such as the device of FIGS. 31 and 32. The surgeon first selectsthe detachable tubular member 40 of desired length, for example based onthe abdominal wall thickness. The tubular member 40 is attached (FIG.34) so that the device is ready for deployment. The distal ring 11 isdeployed in the abdomen as described above. The sleeve 12 is pulledupwardly in the direction of the arrow A whilst pushing down on theproximal ring 24 in the direction of the arrow B. Retraction of theincision 1 commences and the tubular member 40 begins to enter themargin of the incision 1 (FIG. 36). As the pulling and pushing action iscontinued the tubular member 40 is fully deployed creating an instrumentworking channel in the wound opening 13 (FIG. 37). The device isextremely low profile, easy to deploy, and creates an excellent workingchannel which provides maximum flexibility in instrument manipulation.

Referring to FIGS. 38 and 39 there is illustrated another instrumentaccess device which is similar to those described above and like partsare assigned the same reference numerals. In this case the valve housing27 is connected to the inner proximal ring 25 by a suitable connectionsuch as a flexible sleeve or corrugated tube 60. In use, the tubularmember 40 is flexible relative to the proximal anchor which may bebeneficial in reducing drag/friction.

Another access device of the invention is illustrated in FIG. 40. Inthis case, the free end of the sleeve 12 is external of a valve such asa lipseal valve 70 which is connected to the inner proximal ring 25 bymeans of a flexible connecting sleeve 75.

The retractor is easily deployed as the free end of the sleeve 12 whichis pulled on for deployment is readily accessible. The operation of thisdevice is illustrated in FIGS. 41 and 42. It will be noted that in viewof the flexible connection 75 tilting of the instrument does not cause aleak path. This arrangement may be used with any suitable valve(s)and/or seal(s) 20, as illustrated in FIG. 43.

Another access device similar to that of FIGS. 40 to 42 is illustratedin FIGS. 44 to 46. In this case the flexible connection is provided by acorrugated tube 80.

A further access device of the invention is illustrated in FIGS. 47 to49. It will be noted that in this case a proximal inner ring 85 isundersized with respect to the receiver of an outer proximal ring 86. Asillustrated in FIG. 49 when the instrument 3 is tilted off its verticalaxis, the valve housing 27 can move due to this clearance withoutcompromising the seal between the lipseal 70 and the instrument 3. Thus,off-axis movement is accommodated without compromising the seal to theinstrument 3.

Referring to FIGS. 50 to 55 a self locking retractor of the typedescribed above has a valve/seal provided by a body of gelatinouselastomeric material 90 which in this case is simply illustrated asextending across the inner proximal ring 25. The gelatinous elastomericbody 90 may have a pin hole 91 for ease of insertion of an instrument 3.The gel 90 deforms as the instrument 3 is inserted. If there is apre-made pinhole 91, this facilitates entry. If there is no pinhole, theleading edge of the instrument 3 will eventually pierce the material. Inuse the gel 90 seals around the instrument shaft 5. Upon withdrawal ofthe instrument 3, the hole 91 in the gel 90 self-seals closed.

FIGS. 56 to 58 illustrate the use of a gelatinous elastomeric seal/valve95 as described above with reference to FIGS. 50 to 55 with a valvehousing 96 of the type described above.

Referring to FIGS. 58(a)(i) to 58(c)(iii) there is illustrated anotherinstrument access device 500 according to the invention, which issimilar to the instrument access device of FIGS. 56 to 58, and similarelements in FIGS. 58(a)(i) to 58(c)(iii) are assigned the same referencenumerals.

In this case the seal/valve housing of the device 500 comprises ahousing body 300 and a housing cap 301.

The housing body 300 comprises a reception space 305 for receiving thegelatinous elastomeric seal 302 with the pinhole opening 303 extendingtherethrough. As illustrated in FIG. 58(a)(ii), the reception space 305has an open proximal end which acts as an inlet through which the seal302 may be located in the reception space 305. The housing body 300comprises a plurality of upstanding male pins 304 which may beco-operatively associated with corresponding female openings 306 in theseal 302 to control location of the seal 302 in the reception space 305.

In this case the seal 302 is formed separately to the housing body 300.For example, the seal 302 may be formed by casting.

The housing body 300 is mounted to the proximal ring member 25 in asnap-fit arrangement (FIG. 58(c)(i)). When mounted to the proximal ringmember 25, the distal end of the housing body 300 extends distally ofthe proximal ring member 25 and the housing body 300 is located radiallyinwardly of the proximal ring member 25.

The housing cap 301 is mounted to the housing body 300 in a snap-fitarrangement to partially close the proximal end inlet of the receptionspace 305. In this manner the housing cap 301 retains the seal 302 inposition in the reception space 305. The housing cap 301 issubstantially annular in shape with a central opening to facilitateaccess to the seal 302 in the reception space 305.

The housing body 300 may be mounted to the proximal ring member 25before or after retraction of a wound opening.

In use, a wound opening 13 is made in the abdominal wall 2 and thedistal O-ring 11 is inserted through the wound opening 13 into the woundinterior. The seal housing and the proximal ring members 24, 25 arelocated externally of the wound opening 13 (FIG. 58(c)(ii)). The sealhousing may be mounted to the inner proximal ring member 25 before orafter insertion of the distal O-ring 11 through the wound opening 13.

To retract laterally the sides of the wound opening 13, the outerproximal ring member 24 is pushed distally, which causes the innerproximal ring member 25 and the seal housing to move distally, while thefree, proximal end of the sleeve 12 is pulled proximally (FIG.58(c)(iii)). An instrument may then be inserted through the pinholeopening 303 of the seal 302 to access the wound interior in a sealedmanner.

The excess proximal portion of the sleeve 12 may be removed, for exampleby cutting away, after retraction of the wound opening 13, asillustrated in FIG. 58(c)(iii).

Alternatively the excess proximal portion of the sleeve 12 may be sealedto the outer proximal ring member 24 or to the housing body 300, forexample using a clamp, to enhance the sealing effect of the instrumentaccess device 500.

As noted previously, the instrument access device 500 is particularlysuitable for retracting relatively small wound openings, for examplewound openings having a diameter of less than 40 mm, such as between 3mm and 35 mm, typically between 5 mm and 12 mm. The instrument accessdevice 500 is thus suitable to facilitate access of relatively smalllaparoscopic instruments, for example instruments having a diameter ofless than 40 mm, such as between 3 mm and 35 mm, typically between 5 mmand 12 mm.

Because of the relatively small size of the instrument access device500, the wound opening 13 may be retracted by moving the sleeve 12relative to the proximal ring members 24, 25 in a single actuation step.In particular the entire circumference of the sleeve 12 may be grippedby a single hand of a user, and opposite sides of the outer proximalring member 24 may be gripped by the other hand of the user. The sleeve12 may then be pulled proximally while the outer proximal ring member 24is pushed distally to retract the wound opening 13 in a single actuationstep.

It will be appreciated that more than one opening may be providedextending through the seal 302. For example, two pinhole openings may beprovided, spaced-apart from one another, extending through the seal 302.In this case access may be gained to the wound interior with more thanone instrument by extending an instrument through each opening in theseal 302.

FIGS. 58(d) and 58(e) illustrate a seal/valve housing of anotherinstrument access device according to the invention, which is similar tothe seal/valve housing of FIGS. 58(a)(i) to 58(c), and similar elementsin FIGS. 58(d) and 58(e) are assigned the same reference numerals.

In this case, the housing body 300 has an insufflation lumen 313extending therethrough, the seal 302 has an insufflation lumen 312extending therethrough, and the housing cap 301 has an insufflationlumen 311 extending therethrough. As illustrated in FIG. 58(e), thethree insufflation lumena 313, 312, 311 are in alignment, and thelongitudinal axis of each insufflation lumen 313, 312, 311 is parallelto the longitudinal axis of the instrument access device. Aninsufflation tube 310 may be inserted into the insufflation lumen 311 ofthe housing cap 301 to insufflate a wound interior (FIG. 58(e)).

In FIGS. 58(f) and 58(g) there is illustrated another instrument accessdevice 320 according to the invention comprising a seal/valve housing,which is similar to the seal/valve housing of FIGS. 58(d) and 58(e), andsimilar elements in FIGS. 58(f) and 58(g) are assigned the samereference numerals.

In this case the instrument access device 320 comprises a temporaryinsufflation seal 321 fixed to the housing cap 301 at the proximal endof the housing cap insufflation lumen 311. The seal 321 seals theinsufflation lumena 311, 312, 313 to prevent discharge of gas from theinsufflated wound interior. The seal 321 may be pierced by a pointeddistal end of the insufflation tube 310, for example if it is requiredto further insufflate the wound interior.

Once the access device 320 has been fired, and the excess sleeve 12removed, the insufflation tube 310 can be connected by piercing thetemporary seal 321 which maintains pneumoperitoneum.

The distal ring 11 of the device 320 is configured to be sufficientlyflexible for ease of insertion of the distal ring 11 through the woundopening 13 prior to retraction. The distal ring 11 is also configured tobe sufficiently rigid to anchor the device 320 in position in the woundopening 13 during retraction of the wound opening 13. The sleeve 12 hassufficient strength to facilitate transmission of the retraction forcerequired to retract the wound opening 13.

It will be appreciated that the distal ring may be provided in anysuitable configuration for ease of insertion through the wound opening13 prior to retraction. For example at least part of the distal ring 11may be provided in the form of a shape-memory material, such as Nitinol.

Referring to FIGS. 58(h) and 58(i) there is illustrated a furtherinstrument access device 330 according to the invention, which issimilar to the instrument access device 320 of FIGS. 58(f) and 58(g),and similar elements in FIGS. 58(h) and 58(i) are assigned the samereference numerals.

In this case the instrument access device 330 comprises an intermediateconnector 331 to connect the insufflation tube 310 in communication withthe insufflation lumena 311, 312, 313. As illustrated the intermediateconnector 331 is substantially “L”-shaped. In this manner theinsufflation tube 310 may be connected in communication with theinsufflation lumena 311, 312, 313 with the longitudinal axis A-A of theinsufflation tube 310 at the distal end of the insufflation tube 310substantially perpendicular to the longitudinal axes B-B of theinsufflation lumena 311, 312, 313.

The access device 330 has an alternative insufflation connection meansin the form of a tube 331 with an angle and a valve connector. The valveconnector may be closed when not connected to the insufflation supply310 (FIG. 58(h)).

FIGS. 59 to 61 illustrate a still further instrument access device ofthe invention which in this case has a sheet of film material 100extending across the inner proximal ring 25. A valve housing 101 ismounted to an outer proximal ring 104, for example by snap fitting and agelatinous elastomeric seal 102 seals to an instrument 3 which in usepierces through the gel 102 and through the proximal film 104.

Referring to FIGS. 62 to 64 there is illustrated another instrumentaccess device with valve(s) 20. Again, as in some previous embodimentsthe sleeve 13 is pulled upwardly on deployment, leaving the valve 20free of sleeve material.

Referring to FIGS. 65 to 70 there is illustrated another instrumentaccess device 200 according to the invention, which is similar to thedevices of FIGS. 13 to 16 and FIGS. 56 to 58, and similar elements inFIGS. 65 to 70 are assigned the same reference numerals.

In this case the sleeve 12 is fixedly attached at one end to the innerproximal ring 25, extends distally in a first layer to the distal ring11, is looped around the distal ring 11, extends proximally in a secondlayer to the proximal rings 25, 24, and passes proximally between theinner proximal ring 25 and the outer proximal ring 24.

The tubular member 40 is integrally formed with the housing 27, and thehousing 27 is mounted to the inner proximal ring 25.

The seal/valve 95 is provided in the form of a gelatinous elastomericmaterial which is mounted to the housing 27. The seal/valve 95 has apinhole opening 196 extending therethrough through which an instrument 3may be extended. The opening 196 is biased towards a closedconfiguration.

A lumen 150 extends through the tubular member 40 through which aninstrument 3 may be extended. The tubular member 40 has a distal opening142 at a distal end 141 of the tubular member 40.

The tubular member 40 has a skived distal end 141, in this case. Inparticular the plane of the distal opening 142 is inclined relative tothe longitudinal axis of the tubular member 40, for example inclined atan angle of 45°. This configuration results in a low-profile, taperedleading end for the tubular member 40 which tapers to a point 143.

The benefit of having the truncated/skived tubular member is that thepoint 143 on the leading edge of the truncated member 40 more easilyfinds the narrow, unretracted hole of the incision 1. As it advancesdownwards, the taper 141 gradually spreads the incision 1 open.

The distal end 141 of the tubular member 40 is truncated, e.g. at anangle of 45°. This yields a narrow leading edge 143 on the tubularmember 40 which more easily locates the incision 1, through which thedistal ring 11 and the sleeve 12 have already been passed. Furthermorethe taper will aid the retraction of the incision 1 as it advancesdownwards.

The length of the tubular member 40 relative to the abdominal wallthickness may vary.

Upon pulling of the sleeve 12 proximally and pushing of the tubularmember 40 distally, the incision 1 is retracted by a combined action ofthe skived distal end 141 of the tubular member 40 forcing the sides ofthe incision 1 apart and of the sleeve 12 pulling the sides of theincision 1 laterally, as illustrated in FIG. 69. The skived distal end141 of the tubular member 40 assists in guiding the point 143 of thetubular member 40 to the unretracted incision 1, for subsequentadvancement of the tubular member 40 through the incision 1.

After insertion of the tubular member 40 into the incision 1, the point143 of the tubular member 40 is located within the wound interiordistally of the incision 1. However it will be appreciated that thelength of the tubular member 40 may be adjusted to suit the particularanatomy of a patient and/or to suit the preferences of a surgeon. Incertain cases after insertion of the tubular member 40 into the incision1, the distal end of the tubular member 40 may be located within theincision 1 proximally of the wound interior.

FIGS. 70(a) to 70(f) illustrate another instrument access device 400according to the invention, which is similar to the instrument accessdevice 200 of FIGS. 65 to 70, and similar elements in FIGS. 70(a) to70(f) are assigned the same reference numerals.

In this case the inner proximal ring 25 has a seal 401 extending acrossthe inner proximal ring 25. The seal 401 prevents gas leakage from theinsufflated wound interior when the wound opening has been retracted(FIG. 70(b)).

The housing 27 is mountable to and demountable from the inner proximalring 25 in a snap-fit arrangement (FIGS. 70(e) and 70(f)). Upon mountingof the housing 27 to the inner proximal ring 25 after the wound openinghas been retracted, the pointed tip 143 of the tubular member 40 piercesthe seal 401 (FIGS. 70(d) and 70(e)).

Mounting of the housing 27 to the inner proximal ring 25 proceeds in amanner similar to that described previously with reference to FIGS. 26to 28.

FIGS. 70(a) to 70(f) illustrate a modular instrument access device 400.The gel valve 95 has been separated from the retractor base 25. It maybe easier to introduce a cannulated gel housing 27 into an incision thisway, rather than trying to do it at the same time as the retractingphase. FIG. 70(a) illustrates the disc of film 401 mounted in theproximal ‘O’ ring 25 to maintain pneumoperitoneum. When pneumoperitoneumhas been established, the film 401 prevents pressure loss. FIG. 70(d)illustrates the leading tip 143 of the truncated cannula 40 beginning topierce the disc of film 401. In FIG. 70(e) the disc of film 401 has beenpierced. FIG. 70(f) illustrates the snap-fit connection between the gelhousing 27 and the proximal ‘O’ ring 25 of the retractor 400.

Referring to FIGS. 70(g) to 70(i) there is illustrated anotherinstrument access device 410 according to the invention, which issimilar to the instrument access device 400 of FIGS. 70(a) to 70(f), andsimilar elements in FIGS. 70(g) to 70(i) are assigned the same referencenumerals.

In this case, the sleeve 12 extends distally from the inner proximalring 25 to the distal ring 11, loops around the distal ring 11, extendsproximally from the distal ring 11 to the proximal rings 24, 25, extendsbetween the inner proximal ring 25 and the outer proximal ring 24, andextends proximally to the housing 27 to which the sleeve 12 is fixedlyattached. Before the housing 27 is mounted to the inner proximal ring25, any gas leakage from the wound interior through the retracted woundopening is contained within the sleeve 12, and thus pneumoperitoneum ismaintained (FIG. 70(h)). No seal is provided, in this case, extendingacross the inner proximal ring 25.

FIGS. 70(g) to 70(i) illustrate another modular instrument accessdevice, the gel housing 27 with the cannula 40 is fixed to the proximalend of the sleeve 12. A snap fit connection is used to secure the gelhousing 27 to the proximal ‘O’ ring 25 of the retractor 410.

In FIGS. 71 to 73 there is illustrated another instrument access device340 according to the invention, which is similar to the instrumentaccess device 200 of FIGS. 65 to 70, and similar elements in FIGS. 71 to73 are assigned the same reference numerals.

In this case no tubular member is provided extending distally from thehousing 27.

The outer proximal ring 341 is releasably mounted to the inner proximalring 25, in this case. In particular the outer proximal ring 341 has acurved engagement surface which extends in cross-section for aquarter-revolution, as illustrated in FIGS. 71 and 72. The curvedengagement surface rests upon the proximal side of the inner proximalring 25, with the sleeve 25 extending between the inner proximal ring 25and the outer proximal ring 341, to mount the outer proximal ring 341 tothe inner proximal ring 25. This arrangement enables the outer proximalring 341 to be removed after retraction of the wound opening (FIG. 73).

In use, the distal ring 11 is inserted through the wound opening intothe wound interior, and the inner proximal ring 25 is located externallyof the wound opening with the sleeve 12 extending from the distal ring11 to the inner proximal ring 25 in the double-layer arrangement. Theouter proximal ring 341 is then mounted to the inner proximal ring 25with the sleeve 12 extending therebetween (FIG. 71).

The sleeve 12 is then pulled proximally while pushing the outer proximalring 341 distally. The outer proximal ring 341 engages the innerproximal ring 25 and thus the housing 27, the inner proximal ring 25 andthe outer proximal ring 341 all move distally to retract laterally thesides of the wound opening (FIG. 72).

After retraction of the wound opening, the outer proximal ring 341 maybe removed while the distal ring 11, the inner proximal ring 25 and thesleeve 12 remain in position retracting the wound opening (FIG. 73).

The outer proximal ring 341 acts as a guide to guide movement of theinner proximal ring 25 relate to the sleeve 12. In this case, the outerproximal ring 341 does not act as a locking mechanism to lock the sleeve12 with the wound retracted.

FIGS. 71 to 73 show how only half an outer proximal ring 341 is neededto provide support when firing the instrument access device 340. Thedevice 340 functions to retract the wound opening without the outerproximal ring 341 (FIG. 73).

The access ports of the invention can be used in a number of ways. Inone method the retractor is used as described above, the distal innerring 11 being inserted into an incision 1, the outer ring being slid tocontrollably radially expand the incision 1. The retractor may then belocked in position. If necessary, the outer ring can be moved furtherdownwardly to create a larger incision.

In some arrangements an instrument may be bent manually outside the bodyand the bent instrument is delivered through the access port to readilyaccess the operative site.

In a further embodiment an instrument is inserted into the access portand the surgeon uses the abdominal wall itself to bend the instrumentand then insert the bent section further into the abdomen.

It will be appreciated that the instrument access device of theinvention may have a valve or seal in the form of a gelatinouselastomeric material, or in any other suitable form, for example a lipseal.

The access ports of the invention have at least some of the followingadvantages:

Controlled Radial Expansion

-   1. Greater access using smaller incision-   2. Can vary incision size as need be (e.g. specimen removal during    lap coli.)    Greater Sealing Capabilities-   1. No gas leakage from the wound margins-   2. Cannot be inadvertently pulled out of the incision-   3. Will seal any incision and never require secondary sealing method    (suture, Hassan port, etc.)    Eliminate Intra-Abdominal Profile-   1. Gives back more working space in the abdomen (critical in pelvic    surgery)-   2. Perineal access for operations such as Radical Prostatectomy.    Protection of Wound from Infection and Cancer Seeding-   1. Tight seal with no “chimney stack” effect-   2. Upon removal all areas of potential contamination are isolated    from the incision    Reduced Extra-Abdominal Profile-   1. Will increase the effective working length of an instrument-   2. Greater working area outside the abdomen    Increase the Freedom of Movement of Conventional Laparoscopic    Instruments

The instrument access device of the invention enables a surgeon to gainaccess to a wound interior using an instrument while minimising theincision size at the wound interior to minimise the possibility ofpost-operative herniation.

The retractor of the invention may be inserted through the abdominalwall as described below. An initial thin incision may be made in theabdominal wall and an inner distal ring of the retractor may be attachedto an insertion tool. The ring is flexible and can be stretched or bentfor ease of insertion through the incision.

In some cases the ring may be inserted through the incision using ablunted or round-nosed obturator tool.

Alternatively the ring may be inserted using an obturator/trocar toolwith a leading cutting blade. In this case the tool itself makes anincision in the abdominal wall, allowing the distal ring of theretractor to be delivered and deployed.

Further means and methods suitable for introducing the instrument accessdevice of the invention into a wound opening, and suitable forwithdrawing the instrument access device of the invention from a woundopening are described in International patent application publishedunder Nos. WO 2004/026153, WO 2004/030547, WO 2004/054456, and WO2005/009257, the relevant contents of which are incorporated herein byreference.

The invention is not limited to the embodiments hereinbefore described,with reference to the accompanying drawings, which may be varied inconstruction and detail.

The invention claimed is:
 1. A method of operating an instrument accessdevice, including a retractor assembly, a retractor seal for positioningat a proximal portion of the retractor assembly, and an instrument valveassembly, the method comprising: retracting a wound opening with theretractor assembly, wherein retracting the wound opening includes:inserting a distal member of the retractor assembly through the woundopening, positioning a retracting sleeve of the retractor assemblywithin the wound opening, and positioning a proximal member of theretractor assembly external to the wound opening; penetrating theretractor seal with the instrument valve assembly, wherein the retractorseal is unperforated prior to penetration of the retractor seal with theinstrument valve assembly; and sealing the retractor assembly forinsufflation, wherein the sealing of the retractor assembly is provided,at least in part, by the instrument valve assembly.
 2. The method ofclaim 1, wherein the instrument valve assembly includes a tapered distalportion for penetrating the retractor seal.
 3. The method of claim 1,wherein penetrating the retractor seal includes penetrating while theretractor seal is supported by the proximal member along an exteriorside of the wound opening.
 4. A method of operating an instrument accessdevice, including a retractor assembly, a retractor seal for positioningat a proximal portion of the retractor assembly, and an instrument valveassembly, the method comprising: retracting a wound opening with theretractor assembly, wherein retracting the wound opening includes:inserting a distal member of the retractor assembly through the woundopening, positioning a retracting sleeve of the retractor assemblywithin the wound opening, and positioning a proximal member of theretractor assembly external to the wound opening; piercing the retractorseal with the instrument valve assembly, wherein piercing the retractorseal includes making an opening through the retractor seal with theinstrument valve assembly; and sealing a proximal end of the retractorassembly for insufflation, wherein the sealing of the proximal end ofthe retractor assembly is provided, at least in part, by the instrumentvalve assembly.
 5. The method of claim 4, wherein piercing the retractorseal includes forcing a tapered distal end of the instrument valveassembly through the retractor seal.
 6. The method of claim 4, furtherincluding positioning the retractor seal along an external side of thewound opening.
 7. The method of claim 4, further including insufflatinga wound interior with gas, and preventing leakage of the gas through thewound opening from the insufflated wound interior by coupling theretractor seal and the instrument valve assembly.
 8. The method of claim4, wherein sealing the retractor assembly includes forming a seal aboutan outer circumference of the proximal member.
 9. The method of claim 4,further including inserting an instrument through the instrument valveassembly.
 10. The method of claim 4, wherein sealing the retractorassembly includes forming a seal about an outer periphery of theinstrument valve assembly.
 11. The method of claim 1, wherein sealingthe retractor assembly includes forming a seal about an outer peripheryof the proximal member by clamping one or more sealing surfaces aboutthe outer periphery of the proximal member.
 12. The method of claim 1,wherein after penetrating the retractor seal, the instrument valveassembly is coupled to the retractor seal.
 13. The method of claim 1,wherein sealing the retractor assembly includes forming a seal about anouter periphery of the instrument valve assembly.
 14. A method ofoperating an instrument access device, including a retractor assembly, aretractor seal for positioning at a proximal portion of the retractorassembly, and an instrument valve assembly, the method comprising:retracting a wound opening with the retractor assembly, whereinretracting the wound opening includes: inserting a distal member of theretractor assembly through the wound opening, positioning a retractingsleeve of the retractor assembly within the wound opening, andpositioning a proximal member of the retractor assembly external to thewound opening; penetrating the retractor seal with the instrument valveassembly; and sealing the retractor assembly, wherein sealing includesbringing an annular recess of the instrument valve assembly intoengagement with the retractor seal, and wherein the annular recess isformed by a portion of an exterior surface of the instrument valveassembly, the portion of the exterior surface having a fixed shape. 15.The method of claim 14, wherein penetrating the retractor seal includesinserting a distal end of the instrument valve assembly through theretractor seal, with an enlarged proximal end of the instrument valveassembly housing an instrument valve.
 16. The method of claim 14,wherein penetrating includes forming an opening through the retractorseal.
 17. The method of claim 14, wherein penetrating includes forcing atapered distal end of the instrument valve assembly through theretractor seal.
 18. The method of claim 14, wherein sealing theretractor assembly includes forming a seal about an outer surface of theproximal member.
 19. The method of claim 14, wherein sealing theretractor assembly includes forming a seal about the annular recess ofthe instrument valve assembly.
 20. The method of claim 1, whereinpenetrating the retractor seal with the instrument valve assemblyincludes creating a perforation in the retractor seal with theinstrument valve assembly.